Data / Medical devices / Japan / GC Asahi Corporation
GC Asahi Corporation: FDA-registered device maker in Aichi, Japan, 4 510(k) clearances
GC Asahi Corporation is registered with the FDA (registration 3004146043) in Aichi, Japan. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 8, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004146043
- Address
- 1-3-3 Kachigawa-Cho Kasugai-Shi, Aichi, Japan, --
- Owner or operator
- GC America Inc. (8030268)
- Roles
- Manufacturer
- First device listed
- April 28, 2005
- Registered through
- 2026
- Brand names listed
- CAVITRON, EPITEX, EPITEX FINISHING, Fuji IX, Fuji IX ART, Fuji Varnish, G-aenial Bulk Injectable, G-aenial Universal Injectable NMF004A and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 8, 2018 | K173500 | NMF004A | EBF | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 6, 2014 | K133836 | OPTIGLAZE COLOR | EBD | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| May 23, 1995 | K951555 | FUJI IX | EMA | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| September 25, 1981 | K812568 | CAVITRON | EMA | Substantially Equivalent | G-C Intl. Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Coating, Filling Material, Resin
- All makers of Cement, Dental
- All makers of Strip, Polishing Agent
- All makers of Material, Tooth Shade, Resin
Updated March 8, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.